Regulatory Specialist

Job description

If you’re tired of being boxed into a tiny corner of Regulatory Affairs, this is the role that finally gives you the ability to work across it all.

A long established Medical Device manufacturer (40+ years in business) is growing fast and looking for a Regulatory Specialist who wants variety, and the chance to shape how things are done as they scale their product portfolio.

What’s in it for you

• Ownership of meaningful end to end regulatory work

• Exciting new product development coming through the pipeline

• Real influence over technical documentation, processes and compliance direction

• Hybrid working with flexibility (3 days onsite)

• Stability and backing from a global group, without losing the small company feel

What you’ll be working on

• MDR compliance across a high classification and varied product range

• New Product Development NPD, building and updating technical files from scratch

• Supporting new product development and EU expansion projects

• Contributing to biocompatibility inputs & CER updates

• Managing global registrations and renewals (US and EU focus, plus ROW exposure)

• Leading PMS activities, product review meetings and contributing to complaints decisions

• Handling vigilance/recall actions, ensuring timelines and reporting requirements are met

What they’re looking for

Now, I know this is a big ask, looking for someone that ticks all areas of Regulatory Affairs, so that isn't the case. We don't need it all!

Ideally the client would be looking for a solid understanding of technical file compilation for MDR compliance and exposure to product submissions at a minimum.

They definitely need someone who enjoys autonomy and likes getting stuck into all aspects of regulatory. This isn't a position where you will be hand held. They're looking for someone to come in and know the landscape well enough to hold your own.

If you’ve ever felt like a tiny cog in a giant RA team, you won’t here.

This is a small, close knit environment where everyone knows each other and your work actually matters.

To be considered, you must:

• Be UK based with the right to work in the UK

• Be happy to be onsite in Sheffield 3 days per week

• Have experience working within Medical Device regulations (4+ years)

Please submit your CV if you'd like to be considered.

Extra information

Status

Open

Education Level

Secondary School

Location

Sheffield

Type of Contract

Full-time jobs

Published at

18-03-2026

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English